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Proximate II Disposable Skin Stapler

by Ethicon Inc.

510(k) K803038

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK803038 Date30 Dec 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAG
FDA applicant
ETHICON, Inc.
Device Class
Class II
Regulation
21 CFR Part 878.4740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Proximate II Disposable Skin Stapler is a surgical stapler designed for the closure of skin. It functions by delivering staples to approximate tissue edges during surgical procedures.

This device is supplied as a single-use, disposable instrument. It has received FDA 510(k) clearance under the regulation number 878.4740.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Proximate II Disposable Skin Stapler?

    This device is designed for the closure of skin. It functions by delivering staples to approximate tissue edges during surgical procedures.

  • Is the Proximate II Skin Stapler intended for reuse?

    No, this device is supplied as a single-use, disposable instrument. It should not be reused to ensure patient safety and device performance.

  • What is the regulatory status of this device?

    The Proximate II Disposable Skin Stapler has received FDA 510(k) clearance under regulation number 878.4740.